The following data is part of a premarket notification filed by Lab Systems, Inc. with the FDA for Tilt/reduced Shear Semi-recline Seating System.
| Device ID | K923365 |
| 510k Number | K923365 |
| Device Name: | TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM |
| Classification | Wheelchair, Powered |
| Applicant | LAB SYSTEMS, INC. 8955 S. RIDGELINE BLVD. UNIT A Highlands Ranch, CO 80126 |
| Contact | Peter Zeeb |
| Correspondent | Peter Zeeb LAB SYSTEMS, INC. 8955 S. RIDGELINE BLVD. UNIT A Highlands Ranch, CO 80126 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-08 |
| Decision Date | 1993-03-24 |